This invention relates to a splittable or peel-away ERCP catheter and more particularly to a method of using a peel-away ERCP catheter the distal end of which has been inserted into the common bile or pancreatic duct via an endoscope which has been guided through the esophagus and stomach and into the duodenum of a patient.
In certain medical applications it is useful to provide a sheath or catheter that is longitudinally splittable for ease of removal from the human body. For example, the use of a splittable catheter permits the removal of a catheter after a guide wire or other material has been placed therethrough without disturbing the guide wire. Various splittable sheaths and catheters exist which have been designed to split longitudinally along the body to peel-away from a catheter, guide wire or other inserted material.
U.S. Pat. No. 4,776,846 to Wells discloses an apparatus and method for preparing a catheter tube which has a longitudinal line of weakness extending axially therealong is a place for preferential splitting. The method includes co-extruding two materials into the tubular cross-sectional shape. One of the materials forms a surface line along the other which extends readily to a level where the thickness of the tubing cross-section thereat is less. When the co-extruded extra material is removed, a grove is in the surface of the tube, which groove permits easy tearing there along.
U.S. Pat. No. 4,983,168 to Moorehead discloses a layered peel-away hollow sheath, for temporarily creating a passageway into a desired body site of a medical patient for placement of one end of an indwelling device at the body site the sheath. The sheath wall comprise at least two layers, the inside layer being cylindrical and the outside layer comprising two semi-cylindrical segments defining opposed axially directed slits or slots therebetween which comprises tear lines such that the sheath manually tears axially along the single layer tear lines into two pieces for removal of the sheath from around the indwelling device.
U.S. Pat. No. 4,801,294 to Okada discloses a catheter for nasogastric intubation comprising a plastic sheath tube and a fixing means of said tube at nose, said tube having a longitudinal tear-off line over the full length thereof and having elasticity and rigidity slightly larger than those of said catheter, said catheter being inserted in said plastic sheath tube slidably.
U.S. Pat. No. 3,550,591 to McGregor discloses an intravenous catheter unit which provides a needle which can be separated from the catheter after the end of the catheter positioned inside the vein to prevent the needle from tearing or damaging the catheter. The hollow needle is provided with a slit which extends along its entire length. In addition the needle is provided with means of the causing the needle to hinge open to widen the slit enough to pass the catheter therethrough. In this way the needle may be separated from the catheter after the catheter is placed inside the vein.
U.S. Pat. No. 4,781,690 to Oshada, et al. discloses a guiding tube for introducing rodlike medical instruments such as a catheter, which can be easily split and removed. The guiding tube comprises a main body provided with a longitudinal slit and formed of a mixture of first and second materials and a stripe detachably embedded liquid-tight in the slit of the main body and formed of the third material which exhibits a good bonding for the second material but a poor bonding for the first material.
U.S. Pat. No. 4,747,833 to Kousai, et al. discloses a medical instrument-guiding tube for guiding a catheter or other rod-like medical instrument into a blood vessel. This guiding tube comprises a hollow-tube body and at least one linear body integrally joined to the tube body along the longitudinal direction of the tube body. The plastic resin forming the tube body has a poor compatibility with that of the linear body. Tube body and the linear body are engaged together through complimentary concave convex arrangement which can be disengaged with reasonable force.
U.S. Pat. No. 4,883,468 to Kousai, et al. discloses a medical instrument introduction cannula which is useful as a guide means for introducing and indwelling a rod-like material instrument such as a catheter and a guide wire. This cannula is removed after use from the medical instrument by being split. This cannula is formed of a hollow tubular body having a strip member consisting of material different from the other portion of the tubular body, which extends over almost the entire length of the tubular body. The strip member has a weld line along the length of the strip member, or consists of a resin which exhibits a good bonding property only to one of the other components forming the tubular body. The tubular body can be split by way of the weld line or the removal of the strip member having such a bonding property. The method of manufacturing the medical instrument introduction cannula by a two-color extruder is also disclosed.
U.S. Pat. No. 4,997,424 to Little relates to an introducer slitter for slitting an introducer tube portion having, for example, a catheter extending therethrough and into a body vessel while the introducer tube is moved rearwardly relative to the catheter to facilitate separating the introducer from the catheter without having to slide the introducer tube portion over the proximal end of the catheter.
U.S. Pat. No. 5,195,978 to Schiffer discloses a rapid exchange over-the-wire catheter which is provided with one or more breakaway elements for progressively exposing the guide wire from the proximal end toward the distal end of the catheter in a simple and efficient manner. The breakaway element may be formed as a longitudinally aligned pull strip provided in the catheter guide wire lumen or as one or more linearly arrayed tubular breakaway segments in the catheter shaft or as a combination of both features.
U.S. Pat. No. 4,813,929 to Semrad discloses a method and assembly of components for effecting closed chest thoracostomy. A guide wire is removed and a chest tube is introduced through a pleural access catheter, which is split off and removed from the chest tube. FIGS. 5 and 6 of the Semrad reference show a splittable access catheter having knobs that when grasped and pulled in a direction away from the body of the catheter will cause the catheter to split.
U.S. Pat. No. 4,243,050 and 4,345,606 to Littleford disclose an apparatus and related method for implanting pacemaker electrodes and similar devices within a patient including an introducer with a tapered end adapted to extend into the patient's body, and a hollow, tubular sleeve. The sleeve is perforated to form a weakened line. The sleeve may be peeled slightly away at the flange to form tabs which may be used to grasp and peel away the sleeve while removing the same from the vein.
U.S. Pat. No. 4,166,469 to Littleford discloses an apparatus and method for inserting an electrode within a patient with a minimal amount of incision which includes the use of an introducer sleeve which is severed or severable along the length thereof. The introducer sleeve is withdrawn from the patient while the electrode is moving through, severing the sleeve wall along the entire length thereof to enable the removal of the sleeve over the connector plug of the electrode.
U.S. Pat. No. 4,306,562 to Osborne discloses a flexible cannula comprising material which tears readily in a longitudinal direction and thus can be easily removed by pulling tabs on opposite sides of the cannula apart from the catheter or other device that has been inserted into the body. The Osborne cannula readily tears in a longitudinal direction along the length of the structure due to the longitudinal orientation of the material from which it is constructed.
Additionally, it is possible to introduce a standard, non-splittable catheter into the gastroentral tract, via an endoscope, until it is adjacent to the bile duct. However, after a guide wire has been introduced through the catheter, difficulties arise when attempting to remove the catheter. For example, the catheter must be pulled over the entire length of the guide wire by a health care provider, while a second health care provider attempts to maintain the guide wire in the bile duct. This results in a tug-of-war caused by the alternating of the pulling of small increments of the catheter out of the channel of the endoscope and the pushing of the guide wire back into the bile duct after a catheter has been pulled.
None of the above disclosed references disclose a peel-away ERCP catheter or a method of using the same for gaining access to the pancreatic or common bile duct. Additionally, none of the above listed references disclose the use of an endoscope having a lumen, the peel-away catheter being inserted therethrough, for introducing a contrast media or a guide wire into the common bile or pancreatic ducts. Further, none of the above disclosed references teach a method for easily removing a long-line catheter from the common bile or pancreatic duct without disturbing the placement of a guide wire therein. There is a need for a method of introducing a dye, guide wire or stent into the common bile or pancreatic duct through a peel-away ERCP catheter introduced into the human body via an endoscope. There is additionally a need for a method of easily removing a catheter inserted into the common bile or pancreatic duct without disturbing the placement of a guide wire therein.